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Zalicus Completes Patient Enrollment in Phase 2b Clinical Trial of Synavive in Rheumatoid Arthritis
Top-line Data Planned for Third Quarter 2012

CAMBRIDGE, Mass., Apr 30, 2012 (BUSINESS WIRE) --Zalicus Inc. (NASDAQ: ZLCS), a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain and immuno-inflammatory diseases, today announced it has completed enrollment with 292 patients enrolled in the SYNERGY trial, a Phase 2b clinical trial designed to evaluate the safety and efficacy of Synavive(R), a low-dose glucocorticoid with the potential for amplified immuno-inflammatory benefits, in patients with rheumatoid arthritis (RA). Top-line results of the clinical trial are expected to be available in the third quarter of 2012.
"The completion of patient enrollment in SYNERGY is an important milestone for Zalicus. We are grateful to the investigators and patients for participating in this study and look forward to reporting top-line results in the third quarter of 2012," commented Mark H.N. Corrigan, MD, President and CEO of Zalicus. "Synavive has already demonstrated early and encouraging signs of clinical efficacy in RA in a previously completed Phase 2a study with statistically significant improvements in ACR20 and DAS28 scores compared to placebo."
Study Design and Objectives
The Phase 2b clinical trial titled SYNERGY (SYNavivE for Reducing signs and sYmptoms of rheumatoid arthritis trial), is a 12-week, five-arm, global, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of Synavive as a treatment for the signs and symptoms of RA in subjects with moderate to severe disease. The trial is being conducted in up to 60 centers throughout the United States, Europe and Latin America. The primary objective of the trial is to evaluate Synavive efficacy compared to placebo, while key additional secondary objectives include evaluating the efficacy of Synavive compared to its individual components (2.7mg of Prednisolone and 360mg of Dipyramidamole) as well as how Synavive performs in comparison to 5mg of Prednisone. Subjects who complete the core SYNERGY trial are eligible to participate in a one-year extension study designed to investigate the long-term safety and durability of response for Synavive. To learn more about the SYNERGY trial please visit www.clinicaltrials.gov.
About Synavive
Synavive is a novel product candidate designed to enhance the anti-inflammatory benefits of glucocorticoids, without associated dose-dependent side effects. Synavive contains the cardiovascular agent dipyridamole and a very low dose of the glucocorticoid prednisolone and has been designed for once-daily use in a unique fixed-dose, aligned release, oral formulation. Synavive is thought to act through a novel multi-target mechanism of action in which dipyridamole synergistically and selectively amplifies prednisolone's anti-inflammatory and immunomodulatory activities by inhibiting key cell mediators of inflammation. In prior proof-of-concept clinical trials, Synavive demonstrated a powerful anti-inflammatory effect in patients with rheumatoid arthritis (RA) and osteoarthritis (OA) and was generally well-tolerated. Synavive is currently in Phase 2 clinical development for the treatment of rheumatoid arthritis (RA). Beyond RA, Synavive has potential in other steroid-responsive diseases such as polymyalgia rheumatica (PMR), lupus (SLE), ulcerative colitis, and Crohn's as well as a potential replacement of NSAIDs and COXIB's in osteoarthritis.
About Zalicus
Zalicus Inc. (Nasdaq: ZLCS) is a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain and immuno-inflammatory diseases. Zalicus has a portfolio of proprietary clinical-stage product candidates targeting pain and immuno-inflammatory diseases and have entered into multiple revenue-generating collaborations with large pharmaceutical companies relating to other products, product candidates and drug discovery technologies. Zalicus applies its expertise in the discovery and development of selective ion channel modulators and its combination high throughput screening capabilities to discover innovative therapeutics for itself and its collaborators in the areas of pain, inflammation, oncology and infectious disease.
To learn more about Zalicus, please visit www.zalicus.com.
Forward-Looking Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 concerning Zalicus, its product candidate Synavive and its potential and its other business plans. These forward-looking statements about future expectations, plans, objectives and prospects of Zalicus may be identified by words like "believe," "expect," "may," "will," "should," "seek," "plan" or "could" and similar expressions and involve significant risks, uncertainties and assumptions, including risks related to the clinical development of Synavive, the unproven nature of the Zalicus cHTS drug discovery technology, the Company's ability to obtain additional financing or funding for its research and development and those other risks that can be found in the "Risk Factors" section of Zalicus' annual report on Form 10-K on file with the Securities and Exchange Commission and the other reports that Zalicus periodically files with the Securities and Exchange Commission. Actual results may differ materially from those Zalicus contemplated by these forward-looking statements. These forward-looking statements reflect management's current views and Zalicus does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release except as required by law.
(c) 2012 Zalicus Inc. All rights reserved.

SOURCE: Zalicus Inc.
Zalicus Inc.
Justin Renz, CFO, 617-301-7575
[email protected]
or
Gina Nugent, 617-460-3579
[email protected]

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Zalicus Completes Patient Enrollment in Phase 2b Clinical Trial of Synavive in Rheumatoid Arthritis
Top-line Data Planned for Third Quarter 2012
CAMBRIDGE, Mass., Apr 30, 2012 (BUSINESS WIRE) --Zalicus Inc. (NASDAQ: ZLCS), a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain and immuno-inflammatory diseases, today announced it has completed enrollment with 292 patients enrolled in the SYNERGY trial, a Phase 2b clinical trial designed to evaluate the safety and efficacy of Synavive(R), a low-dose glucocorticoid with the potential for amplified immuno-inflammatory benefits, in patients with rheumatoid arthritis (RA). Top-line results of the clinical trial are expected to be available in the third quarter of 2012.
"The completion of patient enrollment in SYNERGY is an important milestone for Zalicus. We are grateful to the investigators and patients for participating in this study and look forward to reporting top-line results in the third quarter of 2012," commented Mark H.N. Corrigan, MD, President and CEO of Zalicus. "Synavive has already demonstrated early and encouraging signs of clinical efficacy in RA in a previously completed Phase 2a study with statistically significant improvements in ACR20 and DAS28 scores compared to placebo."
Study Design and Objectives
The Phase 2b clinical trial titled SYNERGY (SYNavivE for Reducing signs and sYmptoms of rheumatoid arthritis trial), is a 12-week, five-arm, global, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of Synavive as a treatment for the signs and symptoms of RA in subjects with moderate to severe disease. The trial is being conducted in up to 60 centers throughout the United States, Europe and Latin America. The primary objective of the trial is to evaluate Synavive efficacy compared to placebo, while key additional secondary objectives include evaluating the efficacy of Synavive compared to its individual components (2.7mg of Prednisolone and 360mg of Dipyramidamole) as well as how Synavive performs in comparison to 5mg of Prednisone. Subjects who complete the core SYNERGY trial are eligible to participate in a one-year extension study designed to investigate the long-term safety and durability of response for Synavive. To learn more about the SYNERGY trial please visit www.clinicaltrials.gov.
About Synavive
Synavive is a novel product candidate designed to enhance the anti-inflammatory benefits of glucocorticoids, without associated dose-dependent side effects. Synavive contains the cardiovascular agent dipyridamole and a very low dose of the glucocorticoid prednisolone and has been designed for once-daily use in a unique fixed-dose, aligned release, oral formulation. Synavive is thought to act through a novel multi-target mechanism of action in which dipyridamole synergistically and selectively amplifies prednisolone's anti-inflammatory and immunomodulatory activities by inhibiting key cell mediators of inflammation. In prior proof-of-concept clinical trials, Synavive demonstrated a powerful anti-inflammatory effect in patients with rheumatoid arthritis (RA) and osteoarthritis (OA) and was generally well-tolerated. Synavive is currently in Phase 2 clinical development for the treatment of rheumatoid arthritis (RA). Beyond RA, Synavive has potential in other steroid-responsive diseases such as polymyalgia rheumatica (PMR), lupus (SLE), ulcerative colitis, and Crohn's as well as a potential replacement of NSAIDs and COXIB's in osteoarthritis.
About Zalicus
Zalicus Inc. (Nasdaq: ZLCS) is a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain and immuno-inflammatory diseases. Zalicus has a portfolio of proprietary clinical-stage product candidates targeting pain and immuno-inflammatory diseases and have entered into multiple revenue-generating collaborations with large pharmaceutical companies relating to other products, product candidates and drug discovery technologies. Zalicus applies its expertise in the discovery and development of selective ion channel modulators and its combination high throughput screening capabilities to discover innovative therapeutics for itself and its collaborators in the areas of pain, inflammation, oncology and infectious disease.
To learn more about Zalicus, please visit www.zalicus.com.
Forward-Looking Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 concerning Zalicus, its product candidate Synavive and its potential and its other business plans. These forward-looking statements about future expectations, plans, objectives and prospects of Zalicus may be identified by words like "believe," "expect," "may," "will," "should," "seek," "plan" or "could" and similar expressions and involve significant risks, uncertainties and assumptions, including risks related to the clinical development of Synavive, the unproven nature of the Zalicus cHTS drug discovery technology, the Company's ability to obtain additional financing or funding for its research and development and those other risks that can be found in the "Risk Factors" section of Zalicus' annual report on Form 10-K on file with the Securities and Exchange Commission and the other reports that Zalicus periodically files with the Securities and Exchange Commission. Actual results may differ materially from those Zalicus contemplated by these forward-looking statements. These forward-looking statements reflect management's current views and Zalicus does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release except as required by law.
(c) 2012 Zalicus Inc. All rights reserved.

SOURCE: Zalicus Inc.

Zalicus Completes Patient Enrollment in Phase 2b Clinical Trial of Synavive in Rheumatoid Arthritis
Top-line Data Planned for Third Quarter 2012
CAMBRIDGE, Mass., Apr 30, 2012 (BUSINESS WIRE) --Zalicus Inc. (NASDAQ: ZLCS), a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain and immuno-inflammatory diseases, today announced it has completed enrollment with 292 patients enrolled in the SYNERGY trial, a Phase 2b clinical trial designed to evaluate the safety and efficacy of Synavive(R), a low-dose glucocorticoid with the potential for amplified immuno-inflammatory benefits, in patients with rheumatoid arthritis (RA). Top-line results of the clinical trial are expected to be available in the third quarter of 2012.
"The completion of patient enrollment in SYNERGY is an important milestone for Zalicus. We are grateful to the investigators and patients for participating in this study and look forward to reporting top-line results in the third quarter of 2012," commented Mark H.N. Corrigan, MD, President and CEO of Zalicus. "Synavive has already demonstrated early and encouraging signs of clinical efficacy in RA in a previously completed Phase 2a study with statistically significant improvements in ACR20 and DAS28 scores compared to placebo."
Study Design and Objectives
The Phase 2b clinical trial titled SYNERGY (SYNavivE for Reducing signs and sYmptoms of rheumatoid arthritis trial), is a 12-week, five-arm, global, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of Synavive as a treatment for the signs and symptoms of RA in subjects with moderate to severe disease. The trial is being conducted in up to 60 centers throughout the United States, Europe and Latin America. The primary objective of the trial is to evaluate Synavive efficacy compared to placebo, while key additional secondary objectives include evaluating the efficacy of Synavive compared to its individual components (2.7mg of Prednisolone and 360mg of Dipyramidamole) as well as how Synavive performs in comparison to 5mg of Prednisone. Subjects who complete the core SYNERGY trial are eligible to participate in a one-year extension study designed to investigate the long-term safety and durability of response for Synavive. To learn more about the SYNERGY trial please visit www.clinicaltrials.gov.
About Synavive
Synavive is a novel product candidate designed to enhance the anti-inflammatory benefits of glucocorticoids, without associated dose-dependent side effects. Synavive contains the cardiovascular agent dipyridamole and a very low dose of the glucocorticoid prednisolone and has been designed for once-daily use in a unique fixed-dose, aligned release, oral formulation. Synavive is thought to act through a novel multi-target mechanism of action in which dipyridamole synergistically and selectively amplifies prednisolone's anti-inflammatory and immunomodulatory activities by inhibiting key cell mediators of inflammation. In prior proof-of-concept clinical trials, Synavive demonstrated a powerful anti-inflammatory effect in patients with rheumatoid arthritis (RA) and osteoarthritis (OA) and was generally well-tolerated. Synavive is currently in Phase 2 clinical development for the treatment of rheumatoid arthritis (RA). Beyond RA, Synavive has potential in other steroid-responsive diseases such as polymyalgia rheumatica (PMR), lupus (SLE), ulcerative colitis, and Crohn's as well as a potential replacement of NSAIDs and COXIB's in osteoarthritis.
About Zalicus
Zalicus Inc. (Nasdaq: ZLCS) is a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain and immuno-inflammatory diseases. Zalicus has a portfolio of proprietary clinical-stage product candidates targeting pain and immuno-inflammatory diseases and have entered into multiple revenue-generating collaborations with large pharmaceutical companies relating to other products, product candidates and drug discovery technologies. Zalicus applies its expertise in the discovery and development of selective ion channel modulators and its combination high throughput screening capabilities to discover innovative therapeutics for itself and its collaborators in the areas of pain, inflammation, oncology and infectious disease.
To learn more about Zalicus, please visit www.zalicus.com.
Forward-Looking Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 concerning Zalicus, its product candidate Synavive and its potential and its other business plans. These forward-looking statements about future expectations, plans, objectives and prospects of Zalicus may be identified by words like "believe," "expect," "may," "will," "should," "seek," "plan" or "could" and similar expressions and involve significant risks, uncertainties and assumptions, including risks related to the clinical development of Synavive, the unproven nature of the Zalicus cHTS drug discovery technology, the Company's ability to obtain additional financing or funding for its research and development and those other risks that can be found in the "Risk Factors" section of Zalicus' annual report on Form 10-K on file with the Securities and Exchange Commission and the other reports that Zalicus periodically files with the Securities and Exchange Commission. Actual results may differ materially from those Zalicus contemplated by these forward-looking statements. These forward-looking statements reflect management's current views and Zalicus does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release except as required by law.

Efectivamente. Yo entré con 3000 acciones. Y por ahora, encantado. Si veo que recorta, pues venderé a 0,83, para recomprar más abajo. Pero mientras, a dejar correr las ganancias!

Más información: Zalicus Is Locked And Loaded: What You Need To Know

I have been following Zalicus (ZLCS) for three years now, and I am still amazed how this stock has been punished and not rewarded for its advancements. I believe this stock is ready to burst in the coming months with huge top line data expected in September of this year.

A brief overview of the company, at the end of the 1st quarter of this year they had 52 million in the bank. There are 113 million shares outstanding with their projected cash burn for the next year of roughly 10 million per quarter from the multiple ongoing trials and advancements in their pipeline.

The big milestone for the Zalicus is Synavive for near term accomplishments. Synavive is a treatment for Rheumatoid Arthritis comprised from the synergy between Dipyridamole and Prednisolone that will delay the side effects from long term steroidal use. It is highly anticipated for the cost saving benefits that it will provide to its patients to postpone the introduction of an extremely expensive last of the line treatment called biologics that costs roughly $20,000 per year. Synavive will also open a market to countries that currently do not have the capability to administer biologics like Russia, India, and China. With the oral dose Synavive projected to cost consumers around $2000 per year, this drug will be in the market by itself creating a lucrative long term money-maker for Zalicus. Synavive is currently in a Phase II b study with top line results eagerly awaited in September of this year. This drug alone, if top line data is positive, should move Zalicus well over 2.00 per share.

Z160 in itself is a global changer if approved. There has not been a new pain drug introduced to the market in over 30 years. This drug was originally partnered with Merck (MRK) years ago before it was de-prioritized and given back to Zalicus because of solubility issues in clinical trials. Zalicus has addressed those solubility issues and is extremely excited with the results thus far, with 6 fold improvement in bioavailability in phase 1 PK study compared to the prior Merck formulation. Zalicus will have two Phase II a studies to start in the 3rd and 4th quarter of this year, and top line data expected late 2013.

Some other points that need to be addressed briefly are Prednisporin (FOV1101) partnered with Sanofi (SNY). Prednisporin has been reiterated by the CEO of Sanofi 5 times in the last year stating a 2015 launch of Prednisporin for the treatment of Allergic Conjunctivitis. A phase III start would trigger a 3 million dollar milestone payment from Sanofi as well as an additional 37 million dollars upon approval with ongoing tiered royalties from sales.

Covidien (COV) stated that they will pursue the approval of the 32mg dose of Exalgo in the second half of this year. This will answer investors' concerns over ongoing royalty revenue. If you do some quick research for Exalgo reviews you will find that many patients are already being prescribed 2 16mg pills daily for pain relief. This new 32mg dosage will take the lion's share of the market and exponentially increase royalty revenue as well as keep the generic from Watson Pharmaceuticals (WPI) from deteriorating Zalicus's revenue stream from Covidien.

Disclosure: I currently hold shares of Zalicus and I am long with a price target of $3.00 within the next 6 months with positive top line data from Synavive

Ya iba siendo hora que fuera dando alegrias, que yo compré el primer paquete por encima de 1$!!
mientras tanto he ido acumulando pequeñas cantidades.

Buenos días.

El texto es del jueves pasado, y el viernes pego arreón. A ver que hace hoy, pero yo hasta mediados de agosto que se vayan viendo los resultado de la fase 2b yo estaría muy atento no sea que me enganche.

Saludos